EU AI Act & MDR/IVDR: Decoding the New Dual Compliance Roadmap for AI Medical Devices

Medical Device Global Market Access · Feb 5, 2026 · 3m

This episode explores the critical intersection of the new European Union AI Act and the existing Medical Device and In-Vitro Diagnostic Regulations (MDR/IVDR). We unpack the challenges of dual compliance for manufacturers of AI-enabled medical devices and explain how the recent joint guidance from the Medical Device Coordination Group and the Artificial Intelligence Board (MDCG 2025-6 / AIB 2025-1) provides a much-needed roadmap for integrating these two complex regulatory frameworks. Key Questions: - What is the EU AI Act and how does it specifically impact medical device manufacturers? -…